Senior Manager Pharmacovigilance Quality Assurance RD Quality and Compliance
Senior Manager Pharmacovigilance Quality Assurance RD Quality and Compliance
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Job Description
The Role:
Reporting to the Director of Pharmacovigilance Quality Assurance (PVQA) Research & Development Quality and Compliance (RDQ&C) the Senior Manager PVQA plays a key role in strengthening Modernas pharmacovigilance quality function in the region. This position provides strategic oversight of PV quality systems audits and inspections while ensuring compliance with global and regional regulatory requirements.
The role involves close collaboration with Modernas Clinical Safety and Pharmacovigilance (CSPV) organization Global Regulatory Science (GRS) Global Medical Affairs (GMA) and local affiliates ensuring consistent implementation of quality standards regulatory requirements and compliancerelated initiatives. The individual will lead complex pharmacovigilance audits support regulatory inspections across EMEA and contribute to CAPA and issue management processes.
This position requires an experienced PV quality professional with a strong auditing background the ability to influence at multiple levels of the organization and a proactive approach to quality risk management.
Heres What Youll Do:
Provide expert PV quality assurance guidance and support to internal stakeholders ensuring compliance with global pharmacovigilance regulations and best practices.
Plan conduct and report on riskbased pharmacovigilance audits of Moderna affiliates global PV systems vendors and business partners.
Ensure Moderna affiliates and functions are fully prepared for GVP regulatory inspections providing strategic support before during and after inspections.
Ensure endtoend PV audit activities are timely and compliant.
Provide strategic input to the planning and riskassessment for the global PV audit program (e.g. vendor system affiliate & partner audits).
Oversee CAPA development closure and as needed escalation for CAPAs associated or impacting pharmacovigilance.
Provide input into the R&D issue management impacting the local and global PV system to ensure early detection of issues development of corrective and preventative actions (CAPA) tracking of CAPA completion and assessment of effectiveness.
Identify and implement process enhancements to strengthen the PVQA department oversight and ensure regulatory expectations are met.
Remain current with industry trends and draft regulations/guidance.
Participate in adhoc RDQ&C compliance projects and initiatives.
Contribute to the continuing development of a quality culture at Moderna.
Approximately 50 of time is spent in the audit role.
Approximately up to 30 travel required.
Heres What Youll Bring to the Table:
BS/BA 10 years) MS 8 years) or PhD 7 years) in Life Sciences Pharmacy or a related field.
Extensive experience in pharmacovigilance operations and/or GVP Quality Assurance within a global biotech pharmaceutical or CRO environment.
Indepth knowledge of relevant FDA EMA pharmacovigilance guidelines and local/regional GVP regulations.
Handson experience of planning leading and reporting on global pharmacovigilance audits
Experienced in CAPA management and issue resolution
Working knowledge of relevant FDA EU ICH Pharmacovigilance guidelines and regulations preferred.
Experience working with CROs vendors and relationship management preferred.
Excellent auditing skills and ability to communicate significant observations to internal and external stakeholders in a sound and factual manner.
Strong interpersonal skills and ability to provide training and mentoring to auditor trainees and junior staff.
Strong leadership skills with ability to effectively organize and execute tasks.
Ability to work both independently and in a team environment.
Excellent communication and presentation skills both verbal and written.
Ability to influence and negotiate effective solutions excellent interpersonal skills.
Ability to manage multiple projects in a fastpaced environment.
Ability to collaborate effectively in a dynamic crossfunctional matrix environment.
At Moderna we believe that when you feel your best you can do your best work. Thats why our global benefits and wellbeing resources are designed to support youat work at home and everywhere in between.
- Quality healthcare and insurance benefits
- Lifestyle Spending Accounts to create your own pathway to wellbeing
- Free premium access to fitness nutrition and mindfulness classes
- Family planning and adoption benefits
- Generous paid time off including vacation bank holidays volunteer days sabbatical global recharge days and a discretionary yearend shutdown
- Savingsandinvestments
- Locationspecific perks and extras!
The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.
About Moderna
Since our founding in 2010 we have aspired to build the leading mRNA technology platform theinfrastructure to reimagine how medicines are created and delivered and a worldclass team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission values and mindsets every day our peopleare the driving force behind our scientific progress and our culture.Together we are creating a culture of belonging and building an organization that cares deeply for our patients our employees the environment and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer a Fast Company Best Workplace for Innovators and a Great Place to Work in the U.S.
As we build our company we have always believed an inperson culture is critical to our success. Moderna champions the significant benefits of inoffice collaboration by embracing a 70/30 work model. This 70 inoffice structure helps to foster a culture rich in innovation teamwork and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn contribute and make a meaningful impact.
If you want to make a difference and join a team that is changing the future of medicine we invite you to visit modernatx/careers to learn more about our current opportunities.
Moderna is a smokefree alcoholfree and drugfree work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day please apply!
Moderna is committed to equal opportunity in employment and nondiscrimination for all employees and qualified applicants without regard to a persons race color sex gender identity or expression age religion national origin ancestry or citizenship ethnicity disability military or protected veteran status genetic information sexual orientation marital or familial status or any other personal characteristic protected under applicable law. We consider qualified applicants regardless of criminal histories consistent with legal requirements.
Were focused on attracting retaining developing and advancing our employees. By cultivating a workplace that values diverse experiences backgrounds and ideas we create an environment where every employee can contribute their best.
Moderna is committed to offering reasonable accommodation or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations and Adjustments team at .
#LIDS2Required Experience:
Senior Manager
Employment Type
Full-Time
